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    Summary
    EudraCT Number:2018-003907-20
    Sponsor's Protocol Code Number:C16051
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-05-08
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003907-20
    A.3Full title of the trial
    Open-Label Phase 1 Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients Aged 0 to <18 Years With Relapsed or Refractory Acute Lymphoblastic Leukemia, With or Without Extramedullary Disease, or Relapsed or Refractory Lymphoblastic Lymphoma
    Estudio de fase 1 abierto para evaluar la dosis máxima tolerada, la farmacocinética y la seguridad de ixazomib administrado por vía intravenosa a pacientes pediátricos de 0 a <18 años con leucemia linfoblástica aguda en recaída o resistente, con o sin enfermedad extramedular, o con linfoma linfoblástico en recaída o resistente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Maximum Tolerated Dose, Pharmacokinetics, and Safety of Ixazomib Administered Intravenously to Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Relapsed or Refractory Lymphoblastic Lymphoma
    Estudio para evaluar la dosis máxima tolerada, la farmacocinética y la seguridad de ixazomib administrado por vía intravenosa a pacientes pediátricos con leucemia linfoblástica aguda en recaída o resistente o linfoma linfoblástico recidivante o refractario
    A.4.1Sponsor's protocol code numberC16051
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1225-3528
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/376/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMillennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company Limit
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMillennium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillennium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointDrug Information Call Center
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34900834223
    B.5.5Fax numberNA
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIxazomib
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIxazomib citrate
    D.3.9.1CAS number 1239908-20-3
    D.3.9.3Other descriptive nameIXAZOMIB CITRATE
    D.3.9.4EV Substance CodeSUB177403
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory Acute Lymphoblastic Leukemia and Relapsed or Refractory Lymphoblastic Lymphoma
    Leucemia linfoblástica aguda en recaída o resistente y linfoma linfoblástico en recaída o resistente
    E.1.1.1Medical condition in easily understood language
    Cancer
    Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10065923
    E.1.2Term Lymphoblastic lymphoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the MTD and/or RP2D of ixazomib administered IV in combination with multiagent reinduction chemotherapy in pediatric patients with relapsed/refractory ALL or relapsed/refractory LLy.
    - To define and describe the safety and toxicity of IV ixazomib in combination with reinduction chemotherapy in pediatric patients with relapsed/refractory ALL or relapsed/refractory LLy.
    - To characterize the pharmacokinetics of IV ixazomib in combination with reinduction chemotherapy in pediatric patients with relapsed/refractory ALL or relapsed/refractory LLy.
    -Determinar la DMT o la DRF2 de ixazomib administrado IV en combinación con poliquimioterapia de reinducción en pacientes pediátricos con LLA en recaída o resistente o LL en recaída o resistente.
    -Definir y describir la seguridad y la toxicidad de ixazomib IV en combinación con
    quimioterapia de reinducción en pacientes pediátricos con LLA en recaída o resistente o LL
    en recaída o resistente.
    -Caracterizar la farmacocinética de ixazomib IV en combinación con quimioterapia de reinducción en pacientes pediátricos con LLA en recaída o resistente o LL en recaída o resistente.
    E.2.2Secondary objectives of the trial
    To determine the overall response rate (complete remission [CR] or CR with incomplete platelet recovery [CRp]).
    Determinar la tasa de respuesta global (remisión completa [RC] o RC con recuperación incompleta dlas plaquetas [RCp]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age <18 years at the time of enrollment.
    - Diagnosis of relapsed/refractory ALL—with or without extramedullary disease including central nervous system (CNS)2 (<5 white blood cell [WBC]/μL in the cerebrospinal fluid [CSF] with blasts) and CNS3 (≥5 WBC/μL in the CSF with blasts)—or relapsed/refractory LLy. Patients with mixed-phenotype ALL or mature B (Burkitt-like) leukemia are excluded.
    - Patients with relapsed/refractory ALL must have ≥5% blasts in the bone marrow by morphology.
    - Patients with relapsed/refractory LLy must have measurable disease documented by clinical, radiologic, and histologic criteria.
    - A Karnofsky performance status of ≥50% (for patients aged >16 years) and a Lansky performance status of ≥50% (for patients aged ≤16 years).
    - Adequate organ function as defined in Section 7.1 of the protocol.
    - Failure of 1 or more therapeutic attempts.
    - Full recovery from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy before entering this study, as follows:
     -Cytoreduction with hydroxyurea: Hydroxyurea can be initiated and continued for up to 24 hours before the start of protocol therapy.
     -Cytotoxic therapy: At least 14 days must have elapsed since the completion of the last dose of chemotherapy, except intrathecal (IT) chemotherapy and/or maintenance therapy such as vincristine, mercaptopurine, methotrexate, or glucocorticoids. There is no waiting period for those relapsing on maintenance therapy.
    - Hematopoietic stem cell transplantation (HSCT): Patients who have relapsed after HSCT are eligible, provided they have no evidence of acute or chronic graft-versus-host disease (GVHD), are not receiving GVHD prophylaxis or treatment, and are at least 90 days posttransplant at the time of enrollment.
    - Hematopoietic growth factors: It must have been at least 7 days since the completion of therapy with granulocyte colony-stimulating factor (G-CSF) or other growth factor at the time of enrollment. It must have been at least 14 days since the completion of therapy with pegfilgrastim.
    - Biologic (antineoplastic agent): At least 7 days must have elapsed since the last dose of a biologic agent. For agents that have known adverse events (AEs) occurring beyond 7 days after the end of administration, this period must be extended beyond the time during which AE are known to occur. The duration of this interval must be approved by the project clinician (or designee).
    - Monoclonal antibodies: At least 3 half-lives must have elapsed after the last dose of an administered monoclonal antibody.
    - Immunotherapy: At least 30 days must have elapsed after the completion of any type of immunotherapy (eg, tumor vaccines, chimeric antigen receptor T-cells).
    - Photon radiotherapy (XRT): Craniospinal XRT is prohibited during protocol therapy. No washout period is necessary for radiation given to any extramedullary site other than the CNS; ≥90 days must have elapsed if prior total body irradiation or craniospinal XRT was given.
    - Anthracyclines: Patients must have had a lifetime exposure of <400 mg/m2 of doxorubicin equivalents of anthracyclines.
    - Proteasome inhibitor (PI): Patients with a prior exposure to PIs (eg, bortezomib, carfilzomib) are eligible as long as the patient demonstrated at least a partial response to chemotherapy with a PI.
    -Edad < 18 años en el momento de la inclusión.
    -Diagnóstico de LLA en recaída o resistente con o sin afectación extramedular, incluido el sistema
    nervioso central (SNC)2 (menos de 5 leucocitos/µl en el líquido cefalorraquídeo [LCR] con blastos) y
    SNC3 (5 o más leucocitos/µl en el LCR con blastos), o LL en recaída o resistente. Quedan excluidos los
    pacientes con LLA de fenotipo mixto o leucemia de linfocitos B maduros (de tipo Burkitt).
    -Los pacientes con LLA en recaída o resistente deben tener al menos un 5% de blastos en la médula ósea según la morfología.
    -Los pacientes con LL en recaída o resistente deben presentar enfermedad mensurable documentada según criterios clínicos, radiológicos e histológicos.
    -Estado funcional de Karnofsky ≥ 50% (en pacientes de edad > 16 años) y estado funcional de Lansky
    ≥ 50% (en los pacientes de edad ≤ 16 años).
    -Función orgánica adecuada según se define en la sección 7.1.
    -Fracaso de uno o más intentos terapéuticos.
    -Recuperación completa de los efectos tóxicos agudos de toda quimioterapia, inmunoterapia o
    radioterapia previa antes de acceder al estudio, como sigue:
    -Citorreducción con hidroxiurea: el tratamiento con hidroxiurea puede iniciarse y mantenerse hasta
    24 horas antes del comienzo del tratamiento del protocolo.
    -Quimioterapia antineoplásica: deberán haber transcurrido al menos 14 días desde el final de la
    última dosis de quimioterapia, excepto en caso de quimioterapia intratecal (IT) o tratamiento de
    mantenimiento con vincristina, mercaptopurina, metotrexato o glucocorticoides. No hay un
    período de espera para quienes presenten recaída durante el tratamiento de mantenimiento.
    -Trasplante de células progenitoras hematopoyéticas (TCPH): podrán participar pacientes que hayan
    presentado recaída después de un TCMH, siempre que no tengan signos de enfermedad del injerto
    contra el huésped (EICH) aguda o crónica, que no estén recibiendo profilaxis o tratamiento para la
    EICH y que hayan transcurrido al menos 90 días desde el trasplante en el momento de la inclusión.
    -Factores de crecimiento hematopoyéticos: deberán haber transcurrido al menos 7 días desde el final
    del tratamiento con factor estimulador de las colonias de granulocitos (G-CSF) u otro factor de
    crecimiento en el momento de la inclusión. Deberán haber transcurrido al menos 14 días desde el
    final del tratamiento con pegfilgrastim.
    - Fármaco biológico (antineoplásico): deberán haber transcurrido al menos 7 días desde la última dosis
    de un fármaco biológico. En el caso de fármacos con AA conocidos que aparezcan más de 7 días
    después de la administración, este período deberá prolongarse más allá del tiempo en que se sepa que
    pueden aparecer tales AA. La duración de este intervalo deberá ser aprobada por el médico del
    proyecto (o su representante).
    -Anticuerpos monoclonales: deberán haber transcurrido al menos 3 semividas desde la última
    dosis administrada de anticuerpos monoclonales.
    -Inmunoterapia: deberán haber transcurrido al menos 30 días desde el final de cualquier tipo de
    inmunoterapia (por ejemplo, vacunas tumorales o linfocitos T con receptores antigénicos
    quiméricos).
    -Radioterapia con fotones (XRT): la XRT craneovertebral está prohibida durante el tratamiento del
    protocolo. Para la radiación administrada en cualquier localización extramedular distinta del SNC no
    se necesita un período de lavado; en caso de irradiación corporal total o radioterapia craneovertebral
    deberán haber transcurrido al menos 90 días.
    -Antraciclinas: los pacientes deben haber tenido una exposición durante toda la vida menor de 400
    mg/m2 de equivalentes de doxorubicina.
    - Inhibidores del proteosoma (IP): los pacientes con exposición previa a IP (p. ej., bortezomib,
    carfilzomib) podrán participar siempre que hayan presentado al menos una respuesta parcial a la
    quimioterapia con un IP.
    E.4Principal exclusion criteria
    - For patients with ALL: have isolated extramedullary disease.
    - Have Grade ≥2 peripheral sensory or motor neuropathy, defined by the Modified “Balis” Pediatric Scale of Pediatric Neuropathies, at the time of enrollment.
    - Have a known allergy or intolerance to any of the drugs used in the study except for PEG-asparaginase, for which Erwinia asparaginase may be substituted.
    - Have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment. To be enrolled, the patient must not be receiving vasopressors and should have negative blood cultures for 48 hours.
    - Have a planned administration of chemotherapy, radiation therapy, or immunotherapy, other than the study drugs used for this protocol (during the study period).
    - Have a significant concurrent disease, illness, psychiatric disorder, or social issue that would compromise patient safety or compliance with the protocol treatment or procedures, interfere with informed consent, study participation, follow-up, or interpretation of study results.
    - Have deoxyribonucleic acid fragility syndromes (eg, Fanconi anemia, Bloom syndrome).
    - Have Down syndrome.
    - Have received any investigational products within 28 days before the first dose of study treatment.
    - Are receiving cyclosporine, tacrolimus, or other agents to prevent GVHD after HSCT.
    - Are receiving systemic treatment with strong cytochrome P450 3A (CYP3A) inducers (eg, rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John’s wort) within 14 days before study enrollment.
    - Have Philadelphia chromosome (Ph)-positive ALL or Ph-like ALL and are currently receiving tyrosine kinase inhibitor therapy.
    - Pregnancy and breastfeeding exclusions:
     - Female patients who are pregnant are excluded because fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
    - Lactating females who plan to breastfeed their infants are excluded.
    - Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
    - Major surgery within 10 days before the first dose of study drug.
    -En los pacientes con LLA: presentar enfermedad extramedular aislada.
    -Presentar neuropatía sensitiva o motora periférica de grado 2 o superior, definida según la Escala
    pediátrica de Balis modificada de neuropatía periférica, en el momento de la inclusión.
    -Tener alergia o intolerancia conocida a alguno de los fármacos utilizados en el estudio excepto la
    PEG-asparaginasa, que puede sustituirse por asparaginasa de Erwinia.
    -Tener una infección micótica, bacteriana, viral u otra infección sistémica que muestre
    signos/síntomas persistentes relacionados con la infección sin mejoría a pesar del tratamiento
    apropiado con antibióticos o de otro tipo. Para poder participar, el paciente no debe estar recibiendo
    vasopresores y debe tener hemocultivos negativos durante 48 horas.
    -Tener prevista la administración de quimioterapia, radioterapia o inmunoterapia distinta de los
    fármacos del estudio utilizados en este protocolo (durante el período del estudio).
    -Presentar una enfermedad concomitante, un trastorno psiquiátrico o un problema social que
    pueda comprometer la seguridad del paciente o el cumplimiento del tratamiento o los
    procedimientos del protocolo o interferir en el consentimiento informado, la participación en el
    estudio, el seguimiento o la interpretación de los resultados del estudio.
    -Presentar un síndrome de fragilidad del ácido desoxirribonucleico (p. ej., anemia de Fanconi, síndrome
    de Bloom).
    -Tener síndrome de Down.
    -Haber recibido tratamiento con algún producto en investigación en los 28 días previos a la primera dosis
    del fármaco del estudio.
    -Estar recibiendo ciclosporina, tacrolimús u otros fármacos para prevenir la EICH después de un TCMH.
    -Estar recibiendo tratamiento sistémico con inductores potentes de la isoenzima 3A del citocromo
    P450 (CYP3A) (p. ej., rifampicina, rifapentina, rifabutina, carbamazepina, fenitoína, fenobarbital e
    hipérico) en los 14 días previos a la inclusión en el estudio.
    -Presentar LLA positiva para el cromosoma Filadelfia (Ph) o LLA de tipo Ph y estar en
    tratamiento con inhibidores de la tirosina cinasa.
    -Exclusiones relacionadas con el embarazo y la lactancia:
    Se excluirá a las mujeres embarazadas porque se han observado efectos tóxicos fetales y efectos
    teratógenos con varios de los fármacos del estudio. Es necesaria una prueba de embarazo en las
    mujeres en edad fértil.
    -Se excluye a las mujeres lactantes que tengan previsto amamantar a sus hijos.
    -Pacientes sexualmente activos en edad fértil que no se comprometan a utilizar un método
    anticonceptivo eficaz durante su participación en el estudio.
    -Intervención de cirugía mayor en los 10 días previos a la primera dosis del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Dose-limiting toxicity (DLT) during reinduction chemotherapy.
    - Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicities during reinduction chemotherapy.
    - Clinical assessment of laboratory data.
    - PK parameters after Day 1 and Day 11 administration of ixazomib: area under the plasma concentration-time curve from time 0 to time t and maximum observed plasma concentration.
    - Toxicidad limitante de la dosis (TLD) durante la quimioterapia de reinducción.
    - Toxicidad durante la quimioterapia de reinducción según los criterios terminológicos comunes
    para acontecimientos adversos (CTCAE), versión 5.0.
    -Evaluación clínica de los datos de laboratorio.
    -Parámetros farmacocinéticos después de la administración de ixazomib los días 1 y 11: área bajo
    la curva de concentración plasmática-tiempo desde el momento 0 hasta el momento t y
    concentración plasmática máxima observada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 30 months
    Hasta 30 meses
    E.5.2Secondary end point(s)
    - Overall response rate (CR or CRp).
    Tasa de respuesta global (RC o RCp).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 30 months
    Hasta 30 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Paediatric study
    Estudio Pediatrico
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Escalada de dosis 3 + 3
    3 + 3 dose escalation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end-of-treatment visit will occur after approximately 30 days after the first dose of study drug.
    The single follow-up visit will occur at Day 60 after first dose of study drug.
    La visita de finalización del tratamiento se realizará aproximadamente 30 días después de la primera dosis de fármaco de estudio. La única visita de seguimiento se realizará el día 60 después de la primera dosis del fármaco del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 7
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 18
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The single follow-up visit will occur at Day 60 after first dose of study drug.
    La única visita de seguimiento se realizará el día 60 después de la primera dosis de fármaco de estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-18
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